BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPLETE MOISTUREPLUS

    MDR report key: 870934 · Received June 25, 2007

    Report

    Report Number
    2020664-2007-00062
    Event Type
    Injury
    Date Received
    June 25, 2007
    Report Date
    May 25, 2007
    Manufacturer
    ADVANCED MEDICAL OPTICS, INC.
    Product Code
    LPN
    Removal / Correction Number
    PENDING
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US

    Narratives

    Additional Manufacturer Narrative · 1

    FDA ANTIMICROBIAL EFFECTIVENESS PANEL DOES NOT REQUIRE THE DEVICE TO KILL THE ORGANISM. IT IS UNK IF THE DEVICE FAILED TO MEET SPECIFICATIONS AS WE HAVE NOT RECEIVED THE COMPLAINT SAMPLE FOR ANALYSIS, NOR HAVE WE RECEIVED AN IDENTIFYING LOT NUMBER TO PERFORM PRODUCT INVESTIGATION. THE DEVICE WAS MOST PROBABLY BEING USED FOR TREATMENT, AS THIS TYPE OF DEVICE IS NOT TYPICALLY USED FOR DIAGNOSIS. THE RELATIONSHIP, IF ANY, OF THE DEVICE TO THE REPORTED INCIDENT/ADVERSE EVENT IS UNK. THE COMPLAINANT REPORTED AN ASSOCIATION BETWEEN THE AMO DEVICE AND THE REPORTED EVENT. HOWEVER, BECAUSE WE HAVE NOT RECEIVED THE COMPLAINT SAMPLE FOR ANALYSIS, NOR HAVE WE RECEIVED AN IDENTIFYING LOT NUMBER TO GUIDE OUR TESTING, WE HAVE BEEN UNABLE TO DETERMINE THE RELATIONSHIP. ON MAY 25, 2007, AMO INITIATED AN IMMEDIATE AND VOLUNTARY RECALL OF ITS COMPLETE MOISTUREPLUS CONTACT LENS SOLUTION IN RESPONSE TO INFO PROVIDED THAT DAY BY THE US CENTERS FOR DISEASE CONTROL AND PREVENTION REGARDING EYE INFECTIONS FROM ACANTHAMOEBA.

    Description of Event or Problem · 1

    THE US CENTERS FOR DISEASE CONTROL AND PREVENTION (CDC) MADE DATA AVAILABLE TO AMO SHOWING THAT IT HAD INTERVIEWED 46 PTS WHO HAD DEVELOPED ACATHAMOEBA KERATITIS INFECTIONS REPORTED SINCE 2005. A TOTAL 39 PTS WERE SOFT CONTACT LENS WEARERS, 21 OF WHOM REPORTED USING COMPLETE MOISTUREPLUS. ADD'L INFO PROVIDED BY THE CDC INDICATED THAT ONE PT HAD USED LOT "8803896" (NOT A VALID AMO LOT NUMBER). WE ARE ATTEMPTING TO OBTAIN FURTHER INFO. ROOT CAUSE HAS NOT BEEN ESTABLISHED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMPLETE MOISTUREPLUS LPN ADVANCED MEDICAL OPTICS, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NI YR Other